Not Yet RecruitingPhase 2

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD

15 participantsStarted 2026-07-31

Plain-language summary

The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.

Who can participate

Age range2 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must weigh ≥ 17 kg to be eligible for enrollment.
✓. Participant has provided informed consent/assent before initiation of any study-specific activities/procedures. Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
✓. Age 2 to \< 18 years at the time of screening. For participants who reach the age of legal consent during the clinical study, notification will be required, and a new consent form must be signed by the participant for continuation in the study.
✓. Clinical diagnosis of IgG4-RD.

Exclusion criteria

✕. Receipt of all age-appropriate and locally-required vaccinations before screening.
✕. Participants requiring treatment in addition to or other than glucocorticoids (GCs) for IgG4-RD according to PI's assessment at screening.
✕. Participants who are on GCs for the treatment of IgG4-RD should remain on a stable dose for at least 2 weeks before enrollment (Day 1). Tapering post enrollment will be at PI's discretion.
✕. Participants with any of the following abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
✕. Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality, including any of the following at screening (one repeat test may be conducted to confirm results within the same screening period):
✕. Estimated glomerular filtration rate \< 45 mL/min/1.73 m\^2.
✕. B-cell counts \< one-half of the lower limit of normal (LLN) for age according to the central laboratory.
✕. Diagnosed with a concurrent autoimmune disease that is uncontrolled or requires any prohibited medication (unless approved by the medical monitor).

What they're measuring

Maximum Plasma Concentration (Cmax) of Inebilizumab

Timeframe: Up to Day 561

Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab

Timeframe: Up to Day 561

Clearance (CL) of Inebilizumab

Timeframe: Up to Day 561

Terminal Half-life (t½) of Inebilizumab

Timeframe: Up to Day 561

Volume of Distribution at Steady-state (Vss) of Inebilizumab

Timeframe: Up to Day 561

Change from Baseline in CD20+ B-cell Counts

Timeframe: Baseline and Day 561

Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to Day 561

Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Baseline up to Day 561

Trial details

NCT IDNCT07222553

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-06-10

Contact for this trial

Amgen Call Center

866-572-6436 medinfo@amgen.com

View on ClinicalTrials.gov More Immunoglobulin G4-related Disease trials

Who can participate

Age range2 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must weigh ≥ 17 kg to be eligible for enrollment.
✓. Participant has provided informed consent/assent before initiation of any study-specific activities/procedures. Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
✓. Age 2 to \< 18 years at the time of screening. For participants who reach the age of legal consent during the clinical study, notification will be required, and a new consent form must be signed by the participant for continuation in the study.
✓. Clinical diagnosis of IgG4-RD.

Exclusion criteria

✕. Receipt of all age-appropriate and locally-required vaccinations before screening.
✕. Participants requiring treatment in addition to or other than glucocorticoids (GCs) for IgG4-RD according to PI's assessment at screening.
✕. Participants who are on GCs for the treatment of IgG4-RD should remain on a stable dose for at least 2 weeks before enrollment (Day 1). Tapering post enrollment will be at PI's discretion.
✕. Participants with any of the following abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
✕. Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality, including any of the following at screening (one repeat test may be conducted to confirm results within the same screening period):
✕. Estimated glomerular filtration rate \< 45 mL/min/1.73 m\^2.
✕. B-cell counts \< one-half of the lower limit of normal (LLN) for age according to the central laboratory.
✕. Diagnosed with a concurrent autoimmune disease that is uncontrolled or requires any prohibited medication (unless approved by the medical monitor).

What they're measuring

Maximum Plasma Concentration (Cmax) of Inebilizumab

Timeframe: Up to Day 561

Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab

Timeframe: Up to Day 561

Clearance (CL) of Inebilizumab

Timeframe: Up to Day 561

Terminal Half-life (t½) of Inebilizumab

Timeframe: Up to Day 561

Volume of Distribution at Steady-state (Vss) of Inebilizumab

Timeframe: Up to Day 561

Change from Baseline in CD20+ B-cell Counts

Timeframe: Baseline and Day 561

Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to Day 561

Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Baseline up to Day 561